MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2019-04-30 for POWERFLOW 16G IV PORT INTER A710962 manufactured by Bard Access Systems.
[143714041]
Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown. Investigation summary: the device was not returned for evaluation. Images and medical records were not provided for review. Therefore, the investigation is inconclusive for the alleged inability to aspirate as no objective evidence has been provided to confirm any alleged deficiency with the port/catheter. The root cause could not be determined based upon available information. It is unknown whether patient and/or procedural factors contributed to the event. Possible contributing factors include improper procedure and partial catheter occlusion; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s). Labeling review: a review of product labeling documents (e. G. , procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
Patient Sequence No: 1, Text Type: N, H10
[143714042]
It was reported that during scheduled treatment, the blood was allegedly returned and the device allegedly unable to aspirate. No further treatment was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-01220 |
| MDR Report Key | 8565062 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date Mfgr Received | 2019-01-31 |
| Date Added to Maude | 2019-04-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Street | BLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERFLOW 16G IV PORT INTER |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
| Product Code | PTD |
| Date Received | 2019-04-30 |
| Model Number | A710962 |
| Catalog Number | A710962 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-30 |